FDA 483 - Kohana Pharmacy and Center for Regenerative Medicine Inc. - April 10, 2019

An FDA inspection of Kohana Pharmacy and Center for Regenerative Medicine Inc. in San Luis Obispo, CA, identified significant deficiencies in the production of non-sterile drug products. The firm was cited for using non-pharmaceutical grade components, specifically purified water, in drug formulations. Additionally, the inspection revealed inadequate cleaning procedures for work surfaces and utensils used in the production of hazardous drugs, posing a risk of cross-contamination.